Autorizarea produselor medicinale veterinar în contextul noilor reglementari Europene / nationale
The presentation is an update of the aspects specific to the connection/adoption of the Romanian legislation of the field to that of the EU, respectively EU Regulation 2019/6, of the EU Parliament and of the Council of 11 December 2018, regarding veterinary medicinal products, where they have treated Article 6: Submission of applications for marketing authorizations; Art. 46: Scope of the marketing authorization granted by national procedure, Art. 47: National procedure for granting marketing authorization. It also presents the possible advantages of a national legislative procedure as well as proposals to ease the process of changing the conditions of authorization and variations that require evaluation, as a means of advising small and medium enterprises..
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2022 |
|---|---|
| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:16 |
|---|---|
| Enthalten in: |
Medicamentul Veterinar - 16(2022), 1, Seite 19-23 |
| Sprache: |
Englisch ; Rumänisch |
|---|
| Beteiligte Personen: |
Nica Andrei-George [VerfasserIn] |
|---|
| Links: |
doaj.org [kostenfrei] |
|---|
| Themen: |
A.u.v. drug |
|---|
| Förderinstitution / Projekttitel: |
|
|---|
| PPN (Katalog-ID): |
DOAJ028600932 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | DOAJ028600932 | ||
| 003 | DE-627 | ||
| 005 | 20230307125956.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 230226s2022 xx |||||o 00| ||eng c | ||
| 035 | |a (DE-627)DOAJ028600932 | ||
| 035 | |a (DE-599)DOAJ5cc5f91d3057459d809ea1c144058d13 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng |a rum | ||
| 050 | 0 | |a SF1-1100 | |
| 050 | 0 | |a SF600-1100 | |
| 100 | 0 | |a Nica Andrei-George |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Autorizarea produselor medicinale veterinar în contextul noilor reglementari Europene / nationale |
| 264 | 1 | |c 2022 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 520 | |a The presentation is an update of the aspects specific to the connection/adoption of the Romanian legislation of the field to that of the EU, respectively EU Regulation 2019/6, of the EU Parliament and of the Council of 11 December 2018, regarding veterinary medicinal products, where they have treated Article 6: Submission of applications for marketing authorizations; Art. 46: Scope of the marketing authorization granted by national procedure, Art. 47: National procedure for granting marketing authorization. It also presents the possible advantages of a national legislative procedure as well as proposals to ease the process of changing the conditions of authorization and variations that require evaluation, as a means of advising small and medium enterprises. | ||
| 650 | 4 | |a a.u.v. drug | |
| 650 | 4 | |a authorization | |
| 650 | 4 | |a u.e. regulations | |
| 653 | 0 | |a Animal culture | |
| 653 | 0 | |a Veterinary medicine | |
| 773 | 0 | 8 | |i In |t Medicamentul Veterinar |d Romanian National Association of the Veterinary Products Manufacturers, 2012 |g 16(2022), 1, Seite 19-23 |w (DE-627)DOAJ000107050 |x 20692463 |7 nnns |
| 773 | 1 | 8 | |g volume:16 |g year:2022 |g number:1 |g pages:19-23 |
| 856 | 4 | 0 | |u https://doaj.org/article/5cc5f91d3057459d809ea1c144058d13 |z kostenfrei |
| 856 | 4 | 0 | |u http://www.veterinarypharmacon.com/docs/2409-2022_VD_16(1)_ART.4.ROM.pdf |z kostenfrei |
| 856 | 4 | 2 | |u https://doaj.org/toc/1843-9527 |y Journal toc |z kostenfrei |
| 856 | 4 | 2 | |u https://doaj.org/toc/2069-2463 |y Journal toc |z kostenfrei |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_DOAJ | ||
| 951 | |a AR | ||
| 952 | |d 16 |j 2022 |e 1 |h 19-23 | ||